Topiramate (All indications)

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)2.27 [1.66, 3.10]13%12 studies231,3501,410low ROB3.97 [2.71; .]
Major congenital malformations2.27 [1.66, 3.10]13%12 studies231,3501,410low ROB3.97 [2.71; .]
Oro-facial clefts3.15 [2.12, 4.69]0%8 studies5,6584,639not evaluable ROB5.76 [3.66; .]
Congenital heart defects2.47 [0.98, 6.24]0%5 studies36592not evaluable ROB-
Cleft lip with or without cleft palate4.24 [2.15, 8.38]0%4 studies4,7002,319not evaluable ROB7.96 [3.72; .]
Hypospadias4.03 [1.56, 10.45]0%4 studies3,3901,056not evaluable ROB7.53 [2.49; .]
Limb defects3.56 [0.59, 21.68]0%3 studies581not evaluable ROB-
Neural Tube Defects3.21 [0.62, 16.76]0%4 studies4583not evaluable ROB-
Spina bifida5.51 [0.72, 41.94]0%2 studies619565not evaluable ROB-
Cleft palate0.97 [0.13, 7.18]0%2 studies1,1842,262not evaluable ROB-
Digestive system anomalies6.26 [0.69, 56.84]0%2 studies437not evaluable ROB-
Microcephaly / Small head circumference for gestational age7.34 [3.39, 15.86]0%2 studies18,960565not evaluable ROB14.15 [6.24; .]
Urinary malformations1.68 [0.22, 13.11]0%2 studies14161not evaluable ROB-
Bilateral renal agenesis including Potter syndrome24.05 [1.49, 388.57]-1 study75517not evaluable ROB47.59 [2.34; .]
Bladder exstrophy and/or epispadia22.01 [1.36, 355.32]-1 study82517not evaluable ROB43.51 [2.07; .]
Ebstein's anomaly35.96 [2.22, 583.57]-1 study50517not evaluable ROB71.41 [3.86; .]
Hypoplastic right heart (HRH/HRHS)27.30 [1.69, 441.71]-1 study66517not evaluable ROB54.10 [2.77; .]
16 non statistically significant endpoints reported in only one study

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)1.34 [0.87, 2.05]72%6 studies252,6563,167not evaluable ROB-
Small for gestational age (weight)1.64 [1.13, 2.38]83%7 studies210,1813,477not evaluable ROB2.67 [1.51; .]
Low birth weight (< 2500g)1.51 [1.06, 2.15]17%3 studies91,787883not evaluable ROB2.39 [1.32; .]
Very preterm (28 to 32 weeks)2.53 [1.13, 5.65]-1 study8,590477not evaluable ROB4.49 [1.51; .]
2 non statistically significant endpoints reported in only one study

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
2 non statistically significant endpoints reported in only one study

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
4 non statistically significant endpoints reported in only one study

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Emotional disorders0.92 [0.43, 1.97]48%2 studies466317not evaluable ROB-
2 non statistically significant endpoints reported in only one study

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)9.39 [2.18, 40.53]7%4 studies1470not evaluable ROB18.26 [3.77; .]
Late intrauterine deaths (> 22 weeks)15.37 [0.63, 376.77]0%2 studies3not evaluable ROB-
Early intrauterine death (< 22 weeks)8.47 [0.57, 125.19]0%2 studies34not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis/Risk1.95 [1.14, 3.35]0%4 studies4,588955not evaluable ROB3.32 [1.54; .]
Language disorders/delay1.52 [1.10, 2.10]0%5 studies72,088522not evaluable ROB2.41 [1.44; .]
ASD (Autism spectrum disorder): Diagnosis1.96 [1.12, 3.42]0%3 studies4,560949not evaluable ROB3.34 [1.50; .]
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.78 [0.89, 3.56]41%4 studies12,385353not evaluable ROB-
Neuro-developmental disorders (as a whole)1.49 [0.94, 2.35]0%3 studies10,474950not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.41 [0.46, 4.32]39%3 studies11,84163not evaluable ROB-
ASD (Autism spectrum disorder): Risk2.65 [0.36, 19.38]0%2 studies287not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)3.91 [0.71, 21.54]61%2 studies3,400486not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)2.03 [0.97, 4.24]0%2 studies151498not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis2.38 [1.40, 4.05]-1 study544290not evaluable ROB4.19 [2.14; .]
3 non statistically significant endpoints reported in only one study

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